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Digital innovation

Driving operational improvements and quality of our services

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Science Innovation

Uniquely positioned to shape, validate, and deliver biomarker assessments that strive to improve patient outcomes across diverse Therapeutic Areas

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We are IQVIA Laboratories, a leading clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide biospecimen and consent management solutions.

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Our commitment to customer success is embedded in every facet of our operations.

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Science Innovation

Uniquely positioned to shape, validate, and deliver biomarker assessments that strive to improve patient outcomes across diverse Therapeutic Areas

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Digital Innovation

Driving operational improvements and quality of our services
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Improving human health requires brave thinkers who are willing to explore new ideas and build on successes. Unleash your potential with us.

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We are IQVIA Laboratories, a leading clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide biospecimen and consent management solutions.

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Discovery Sciences

Our labs bring expertise in protein production, antibody discovery, and immunogenicity to help you select the most promising candidates and reduce risk as you move toward IND-enabling studies.
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Biomarker analysis

a CLIA-certified biomarker testing laboratory developing immunoassays used to quantify protein biomarkers in support of drug mechanism of action, pharmacodynamic, prognostic, and predictive clinical studies across all stages of drug discovery and development.
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Central laboratories

Meeting the demands of today’s drug, device and diagnostics development environment requires a next generation service provider.
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Bioanalytical services

One of the world's largest and most respected bioanalytical and ADME laboratory networks. From our global locations, we serve many of the largest pharmaceutical, specialty pharmaceutical and biotechnology companies worldwide.
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Genomics

We offer a range of genomic laboratory services to support drug discovery, precision medicine and clinical development. Our industry-leading team advances research by delivering scientific insights that help clients maximize the value of their data.
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Vaccines

Combining cutting-edge technology platforms and state-of-the-art laboratories with over 35 years of clinical vaccine development.
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Digital innovation

We have a dedicated Digital Innovation department focused on driving operational improvements and quality of our services. We’ve helped create agile and impactful solutions across the organization with the underpinnings of traceability, productivity, quality, and efficiency.
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Therapeutic expertise
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Bioanalytical Services

Discovery and ADME services list

IQVIA Laboratories operates one of the world’s largest and most respected bioanalytical services laboratory networks. We represent a leading clinical trial laboratory services organization with bioanalytical, genomics, vaccines, flow cytometry, anatomic pathology, immunoassay, companion diagnostics and central laboratory services with secure, enterprise-wide biospecimen and consent management solutions. Recognizing that a clinical assay must be reliable over a period of years, IQVIA Laboratories benchmarks all projects using a rigorous bioanalytical method development strategy that includes a common set of SOPs, statistical analysis, and science writing support.

From in vitro ADME screening and discovery and development metabolite identification to DMPK services and regulatory validation, we can help you navigate your large-scale clinical study. Our integrated drug metabolism solutions include high-throughput screening assays, human clearance predictions, drug-drug interaction risk assessments and metabolite profiling to support clinical safety. In addition to the services listed below, we can also provide bundled services for discovery and regulatory-phase packages to enable decision-making in early discovery through IND and beyond.

Bioanalytical/Pharmacokinetics Services

 

Discovery Phase Bioanalysis by LC-MS/MS
Details
Tiered bioanalysis service available Levels 0 – 3 (all non-regulated)
Bioanalytical with optional Pharmacokinetic Analysis: Plasma, Tissues Species selectable, non-compartmental analysis
Bioanalytical with optional Pharmacokinetic Analysis: Dried Blood Spot Species selectable, non-compartmental analysis

 

In Vitro ADME Services

 

High-Throughput Screening Assays

Details
Solubility/Permeability Assays:
 
Solubility: Turbidimetric 10 μM to 100 μM in buffer
Permeability: MDCK MDCK (wild type), MDCK-II cell lines
Permeability: PAMPA Pre-coated PAMPA plate system
Metabolic Stability Assays:
  
Metabolic Stability: Single Point Hepatocytes or microsomes; Species selectable
Metabolic Stability: Intrinsic Clearance Hepatocytes or microsome; Species selectable
Metabolic Stability: Plasma or S9 Species selectable
Inhibition Assays (enzyme):
  
P450 Inhibition: Reversible Single Point Single concentration, P450 selectable (up to seven)
P450 Inhibition: Reversible IC50 Multiple concentrations, P450 selectable (up to seven)
Time Dependent P450 Inhibition: Single Point Single concentration, CYP3A
Time Dependent P450 Inhibition: Multiple Point CYP3A, CYP2B6, CYP2C8, CYP2C9, CYP2C19
Time Dependent P450 Inhibition: IC50 Shift CYP3A or CYP3A4, 2D6 and 2C9 cocktail assays
Inhibition Assays (transporter):
  
Transporter Inhibition: Bile Salt Export Pump (BSEP) Inhibition Vesicles
Reaction Phenotyping Assays:
  
P450 Reaction Phenotyping: Substrate Depletion Microsomes with inhibitors for CYP2C9, CYP2D6, CYP3A
Other Assays:
  
Protein Binding: Plasma, Microsomes, Brain Homogenate, HSA, AAG Equilibrium dialysis HTDialysis or RED devise; Species selectable
Blood to Plasma Ratio Species Selectable
Bundled Tier 1 Screening Assays:
  
Metabolic stability, permeability, CYP inhibition Human liver microsomes, MDCK, CYPs 2C9, 2D6, 3A in cocktail

 

 

Late Stage Discovery to Regulatory Phase Assays

Details
Metabolic Stability Assays:
 
Metabolic Stability: Intrinsic Clearance Hepatocytes and microsomes; Species selectable (±ABT optional)
Metabolic Stability: Glucuronidation (UGT) Clearance Microsomes (liver, intestine, kidney); Species selectable (±BSA)
Metabolic Stability: Low Turnover Drugs Hepatocyte coculture systems (HµREL); Species selectable
Inhibition Assays (enzyme):
 
P450 Inhibition: Hepatocytes Suspended in Plasma CYP2C9, CYP2D6, CYP3A; combined reversible and TDI inhibition model
P450 Inhibition: Reversible IC50 Definitive IC50 for up to 7 P450s/8 assays
P450 Inhibition: Reversible Ki Definitive Ki for selected P450s
Time Dependent P450 Inhibition: I50 Shift IC50 shift following 30 min pre-incubation (part of reversible inhibition IC50 assay)
Time Dependent P450 Inhibition: Kinetics CYPs 1A2, 2B6, 2C8, 2C9, 2C19, 2D6 and 3A; kinact / KI and CLinact
Time Dependent P450 Inhibition: Mechanism Metabolic intermediate (MI) complex formation, CYP3A4
UGT Inhibition: Reversible IC50 UGT1A1, 1A3, 1A4, 1A6, 1A9, 2B7; Definitive IC50 using human liver microsomes
Induction Assays:
 
P450 Induction: mRNA discovery screen in human hepatocytes CYP1A2, CYP2B6, CYP3A4 message RNA assay following 24 hour treatment
P450 Induction: mRNA in 3 human hepatocyte donors with Relative Induction Score CYP3A4, CYP2B6, CYP1A2, CYP2C8, CYP2C9, CYP2C19 mRNA, 48 or 72 hour treatment with basic DDI modeling (± CYP activity evaluation)
Reaction Phenotyping Assays:
 
Hepatocytes with pan-CYP inhibitor (ABT) Estimate CYP vs. non-CYP mediated fraction of metabolism
P450 Reaction Phenotyping: Substrate Depletion Combination of rCYPs to predict HLM fm,CYP using RAF and/or chemical inhibitors
P450 Reaction Phenotyping: Metabolite Formation Combination of rCYPs and/or chemical inhibitors
Estimation of Fraction Metabolized by CYP3A4 and CYP3A5 Combination of rCYPs and/or chemical inhibitors (ketoconazole and CYP3cide)
Aldehyde Oxidase (AO) Reaction Phenotyping: Human Human cytosol or hepatocytes ±Hydralazine (AO inhibitor)
Other Assays:
 
Protein Binding: Equilibrium Dialysis by HTDialysis Method Plasma, microsomes, HSA, AAG; Species selectable; human clinical plasma
Blood to Plasma Ratio Human
Bundled IND-Enabling Assays:
 
In Vitro DDI: CYP inhibition, time-dependent inhibition (TDI) and induction HLMs and human hepatocytes; Assays meet regulatory guidelines for IND

 

Metabolite Profiling and Identification Discovery Services

 

Discovery to Regulatory Phase Assays
Details (Waters Synapt G2-S and Thermo OrbiTrap and Q-Exactive HRMS)
Metabolite Profiling and Identification: Microsomes and Hepatocytes Species selectable; S9, cytosol, or hepatocyte coculture systems available
P450 Reaction Phenotyping: Metabolite Formation Microsomes with inhibitors for CYP1A2, CYP2C9, CYP2D6, CYP3A
Metabolite Profiling and Identification: In Vivo Services Plasma, urine, bile, feces, and/or tissue homogenate; Species selectable
Metabolite Profiling and Identification: Exploratory Profiling Exploratory assessment using unlabeled drug; Preclinical or clinical samples
Metabolite Profiling and Identification: Radioprofiling and MetID Preclinical or clinical samples; Typically plasma, urine, bile, and/or feces
Reactive Intermediate Screen: Glutathione or Cyanide Trapping Agent Microsomes; Species selectable
Reactive Intermediate Screen: Covalent Binding Radiolabel covalent binding in microsomes or hepatocytes, species selectable

 

 

>50 proprietary, large molecule assays performed in 2018

A full range of bioanalytical and ADME services

IQVIA Laboratories operates one of the world’s largest and most respected bioanalytical and ADME laboratory networks. From our global locations, we serve many of the largest pharmaceutical, specialty pharmaceutical and biotechnology companies in North America, South America, Europe and Asia. Our highly trained scientists utilize a range of leading-edge technology, automation and state-of-the-art techniques.

  • In Vitro ADME Assay development and metabolite identification services in support of rapid drug discovery ADME property optimization and regulatory filings
  • Bioanalytical liquid chromatography tandem mass spectrometry (LC/MS/MS) services for the quantitative determination of small molecule drugs and macromolecule therapeutics in support of pharmacokinetic (PK) studies
  • Immunoassay services for Enzyme-Linked ImmunoSorbant Assays (ELISA), mesoscale (MSD), electrochemiluminescence (ECL), and neutralizing antibody assays (NAB) in support of PK and immunogenicity studies
  • Biomarker services for LC/MS and ligand-binding assays for the quantitative determination of bioanalytical biomarkers

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